22 results · 23ms · Sources: EU EUDAMED, US FDA

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InMode RF System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GM HELIX ACQUA IMPLANT,TI,5.0X16

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018

SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC

FDA 510(k)
FDA Unclassified ·Unknown

PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

FDA 510(k)
FDA Class 2 ·Dental

GM HELIX IMPLANT 4.3X13

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·June 6, 2018

GM HELIX IMPLANT 4.3X13

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018

GM DRIVE ACQUA IMPLANT 3.5X8 MM

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018

GM HELIX ACQUA IMPLANT 3.75X11.5

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018

GM HELIX IMPLANT 3.5X10

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·June 29, 2018

GM HELIX ACQUA IMPLANT 3.5X11.5

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018

FREESTYLE LIBRE 3

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE LTD·Product code QBJ·May 21, 2026

GM DRIVE IMPLANT 3.5X10

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·April 20, 2018

UNKNOWN DEPUY ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011

BIOMET CABLE SYSTEM

FDA Adverse Event
Malfunction ·EBI, LLC.·Product code JDQ·June 11, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·October 10, 2014

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·May 17, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 18, 2019

OPTILITE SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·June 5, 2020

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 12, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 18, 2019